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Informed Consent Resources

On January 21, 2019 the Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) will be effective.

Substantive revisions were made to the regulations to “modernize, strengthen, and make more effective” (HHS 2017) the current system of oversight that has been the federal Common Rule since 1991. The revisions are intended to:

Comtinuing review no longer necessary for most non-exempt research activities

New Consent Process requirements

The RIT review process will continue as it is currently with some modifications to existing forms and some researchers may be required to submit additional information. The updated HSRO website will be online January 21, 2019 and the HSRO will assist researchers with the transition during the next few months.

The federal regulations require that certain information must be provided to each subject; these requirements and additional tips for creating informed consent documents are contained in this document.